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Overview

This module is part of the DIA Drug Safety eLearning Program. The Drug Safety Regulatory Requirements module provides information about pharmacovigilance harmonization initiatives and regulatory requirements around world. This module includes harmonization initiatives, key US and EU regulations, the roles that ICH and CIOMS play in drug safety regulations, good clinical and pharmacovigilance practices, and standard operating procedures (SOPs) that support drug safety.

Featured topics

  • Harmonization Initiatives
  • Important US Regulations
  • Important EU Regulations
  • New EU Legislation
  • Good Pharmacovigilance Practices
  • Standard Operating Procedures

Who should attend?

Professionals working in the area of:

  • Drug safety & pharmacovigilance
  • Clinical research and development
  • Marketing approval
  • Postmarketing activities
  • Regulatory affairs
  • Medical affairs
  • Quality assurance/compliance
  • Anyone who would like to enhance their knowledge and understanding of drug safety

Learning objectives

Upon completion of this course, participants should be able to:

  • Identify key harmonization initiatives involved in drug safety
  • Identify important US regulations
  • Identify important EU regulations
  • Describe the roles that the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Council for International Organizations of Medical Sciences (CIOMS) play in drug safety regulations
  • Describe good clinical and pharmacovigilance practice
  • Describe standard operating procedures (SOPs) that support drug safety

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